russett,
I am not sure I will get my ll response done tonight -- been a long day. However I will give it a try.
First re: the trial time for Celebrex for O/A. Would you believe 12 weeks..
<< I'm more concerned with other issues, primarily how fast we can expect consumers to adopt the product which will be determined by ease and convenience of use, portability and durability of the product, effectiveness, marketing, doctor adoption to prescribe and anything else that affects customer adoption and repeat use.>>
Fair enough and I have considered this. Lets look at each issue one at a time.
1) Ease and convenience of use.
No doubt that popping a pill is easier than rubbing on a lotion -- but that has not stopped million of people from using ointments/creams daily that require the same activity.
Granted in the case of Pennsaid, they will have to wash their hands fisrt (I suspect) but I am hopeful that when doctors educate the consumer about the benefits of this route vs oral, a little hand washing will not seem like a big deal. BTW -- most people should was their hands more anyway -- as I am sure you would agree.
2)Portability and durability of the product.
A 60 ml container of Pennsaid will be about the same size as a bottle of pills. In terms of durability, I am sure that you know that most medications have storage directions, particularly about putting them in hot cars. The shelf life for Pennsaid the last I was told, was about 2 years. That seems quite average to me.
3) Effectiveness
I have spoken personally to a number of people who have used the drug, including several doctors -- everyone has said the stuff works. In addition, the trials proved it works. Interestingly NSAIDS only work in 60-65% of people, so if Pennsaid is close to that, we will do OK.
4) Marketing
If we get US approval, I suspect that our partner will do a good job at this, assuming it is J&J.
5) Doctor adoption to prescribe
With DTC advertising that is allowed in the US, I am hoping that, to a degree, the Px will end up asking for it. And again there will an education curve here too for the docs - I hope the drug reps are well versed.
It does point out that a rat can tolerate it better than a monkey.
True -- but the LDL50 was 88gm/Kg of body weight when applied to skin. We both know that, that is one hell of a lot of DMSO.
<<The paper's discussion about DMSO in fruit is a little silly, considering they are talking parts per million,...so
in black leaf tea (the highest amount of DMSO) there is 16 grams per tonne of drink. I imagine it would take a
long time to steep and drink a tonne of tea and get 16 grams of DMSO in us>>
I think what I personally garner from this is that we as humans have been exposed to DMSO for likely thousands of years and as a result we have adapted to metabolizing it very nicely.
Interestingly, I suspect that one could drink an entire bottle of Pennsaid (60 ml is about 1 month's supply) and likely not feel much at all. I doubt the the same could not be said for one month's supply of Celebrex, Vioxx or most of the other NSAIDS.
DMSO WHMIS sheet
You might find this post interesting on SH:
stockhouse.ca
<<Also discussed in that article is the fact that exposure to light, and although not specifically discussed probably heat, causes quick degradation of DMSO,...a problem for storage and ease of use. Leaving this in the car, purse or pocket on a warm day could destroy its effectiveness. It also biodegrades qui>>
A month's supply last about 4 weeks. No assumimg that it would be delivered from production within 6 months (fair) it only has to stay "fresh" for 4 weeks, assuming it is used daily. Also, one has to be carefull about comparing pure DMSO to Pennsaid. I suspect they may have added some sort of stabilizers to the compounding to increase shelf life (just guessing, I realy do not know)
My answer to your question about what did I think the reasons for HC to delay approval were, was buried in
a post to Cal that day. I thought we were discussing amongst ourselves.
Unless is PMd, I assume it is free to be commented on by anyone -- sorry to butt in.
Shareholders are lobbying down in the States for this now. If passed we could discuss specifics a lot easier than we can now.
Agreed - I love to see this too.
Your assumption that everyone will understand
that Pennsaid is better for them, and only an idiot would not see the difference is clear to me,.
Actually, I think it is going to take some consumer education. But I believe that the biggest hurdle is going to be educating busy doctors. I have found with a lot of health educating I have done (>20 years), most people are willing to adopt healthy behaviours once educated, even if there is some inconvenience.
but what percentage of all analgesic pill poppers develop serious side effects to the pills,
A responsible doctor's first credo is -- first do no harm. Any doctor that has had to deal with a bad GI bleed due to oral NSAIDS will appreciate the safety profile of Pennsaid.
Also - doctors in general are fully aware of what NSAIDS can do to people; it is not just GI bleeds were are talking about. There are other side effects too.
<< but because the patient didn't want to take their shirt or pants off all the time to apply,>>
In my mind this just requires a little pre-planning. Most people using this stuff are likely going to be retired, so they will for the most part spend much of their time at home. But even if they were going out shopping for 3-4 hours - would you just not apply some before going out.
A high proportion of these people smoke cigarettes, drink alcohol to excess, and eat all the foods that are bad for them even after warning signs of diabetes, heart problems etc., etc. They won't listen to arguments of severe side effects, rotting guts, etc.
First - 75% of the population think enough of the ill effects of smoking, not to do so. So I have a hard time believing that we are talking about a "high proportion".
Also, older people today are much more aware of benefits of a healthy lifestyle and as they age and things start to wear out they become that more aware and more likley to act in their best interests to preserve what they have left.
Think about the decrease in growth of early adopters of Pennsaid in the early trials in North America a year or so back,... only 3400 users at the end of the trial.
At some point the trial has to end. These trials are expensive and can not go on forever. In addition, I believe these people paid for Pennsaid out of their own pockets. I may stand corrected on that, but I seem to recall that was the case.
As far as WF10,..
I think it is fair to say we share the same views here, including a possible benefit for arthritis.
Well, I lasted longer than I thought I would - take care and thanks for an intelligent dialogue.
MB
PS - please forgive the typos. I am too damned tired to go back and correct them! |
